In a little over a week, the Government will lay out its model for how it intends to regulate the medicinal cannabis market.
It will be the first time medicines will be allowed to bypass the usual fail-safes and go direct to market without clinical proof of safety or measures of effectiveness.
The Ministry of Health’s medicinal cannabis scheme is aimed at creating a regulated, affordable market, and will provide the initial blueprint for licensing, cultivation, manufacturing and product formulations, as well as a prescription and enforcement regime.
A consultation document published in July provided some insight into how this could look — with products ranging from oils, ointments and patches to dried cannabis to be used for vaping in the mix.
However, the rules are still tight, with only registered medicines — in this case MS treatment Sativex — available on GP prescription.
Industry players are hopeful the health authorities will have taken feedback on board since July, and will allow prescriptions for a range of products to be supplied by a single GP rather than through specialist sign-off.
Others, such as Prof Michelle Glass, of the University of Otago’s department of pharmacology and toxicology, have sounded warnings over loosening up the reins.
"Cannabis should not be treated differently from any other medicine," she said.
"It’s a complex plant and not well understood, with medicinal uses that can range from pharmaceutical grade plant-derived medicines through to homegrown remedies."
She had seen no evidence over her 20 years of research that would cause her to circumvent the usual pathway to market, she said.
"That means an assurance of good manufacturing practice standards, ensuring consistency and security across each batch."
What she is referring to is clinical and efficacy trials, which determine side-effect profiles, drug interactions and dosage limits.
But pharmaceutical certification can be prohibitively expensive, cannabis companies say.
"To go through double blind, three stages of trials and get FDA [US Food and Drug Administration] approval could cost you the better part of $1billion by the time your product gets anywhere close to the patient," Soma Medical Research director Greg Marshall said.
Mr Marshall, who is positioning Dunedin-based research company Soma as the “science backbone” to other contenders in the industry, said the capital requirements would “seriously stifle” any investment in a vibrant New Zealand market.
His plan is to provide the research ‘‘back office’’ for an estimated 50 players lining up for potential licenses, the majority of which are now operating in the research field, linked to university labs licensed to use cannabis products.
For major players such as Helius Therapeutics, Eqalis Research, Snowball Effect, Hikurangi, Cannasouth, Nubu, Rua and Puro, the stakes are high.
Even when the rules had been defined there would still be much work to do, Mr Marshall said.
"To ensure companies stand out they will need to highlight their credentials, their investment in intellectual property and baseline understanding of the product and what they can offer in terms of product mix."
That “product mix” went to the heart of the issue, Prof Glass said.
"Cannabis is a diverse species, broken down broadly into tetrahydrocannabinol [THC], the main psychoactive component of the plant, and cannabidiol [CBD], which is described by researchers as a ‘non-intoxicating’ cannabinoid."
While concentrations of THC and CBD across different plants can vary widely, THC is considered more prevalent in recreational use and CBD higher in ‘‘medicinal cannabis’’.
Prof Glass said while anecdotally CBD had benefits, including anti-inflammatory and anxiety-reducing properties, ‘‘to date there hasn’t been any clinical evidence to support this”.
Mr Marshall, however, said the scheme was setting the right direction for New Zealand.
"In California it’s become just another business. In New Zealand we have the ideal growing environment and some pretty damn good farmers, so we’d be silly not to position ourselves in what is historically one of the world’s most valuable crops."
He believed it had the potential to rival kiwifruit exports.
But in terms of its therapeutic use it was more about understanding the science behind products.
"We are about the science behind the product. I can tell you what’s in the product and it’s the same every time, so we think with high-quality testing and short-run clinical trials we could be in a good place for rapid deployment of these whole-plant extracts."
"It’s a complex plant and the reason it impacts is because it touches receptors and organs in different places in different ways.
"That happens anyway but it’s not just you’ve got a THC molecule — there are other things that happen in other receptors and in the body at the same time from the bioactives that you ingest that give you the impact."
To that end Soma has invested in "whole of nutrition" distributors such as a kombucha company, Mr Marshall said.
"We don’t necessarily want to follow the California model, where it wasn’t a standalone prescription but a recommendation that allowed access to a grey market. We can see the best of both worlds but it depends what comes out next week."
